Day Two - CT (Central Time)
Industry leaders share their vision for navigating today's complex landscape.
Analysis of recent legislative actions, regulatory guidance, and enforcement trends affecting pharmaceutical pricing and government program participation.
- Alice Valder Curran - Partner, Global Regulatory, Hogan Lovells
Review of federal court decisions affecting contract pharmacy arrangements, 340B administrative dispute resolution processes, and manufacturer obligations.
- Angie Franks - Chief Executive Officer, Kalderos
- IRA impacts on 340B pricing and identify optimization strategies
- Assess MFP reforms' effect on 340B participation requirements
- Develop compliance approaches across overlapping policies for financial sustainability
- Analyze how PBM formulary decisions may be impacted by MFP implementation, including potential disincentives to include negotiated products and strategies for ensuring continued patient access
- Aaron Vandervelde - Managing Director, Berkeley Research Group, LLC
Hear from an expert panel of attorneys as they each moderate a topic and interactive discussion among attendees, and themselves, on the most pressing issues facing MDRP and Government Pricing.
- Jesse Mendelsohn - Senior Vice President, Model N
- Jeffrey Handwerker - Partner, Arnold & Porter LLP
- John Shakow - Partner, King & Spalding LLP
- Kristie Gurley - Partner, Washington, Covington & Burling LLP
- Meena Datta - Partner, Sidley Austin LLP
- Analyze recent judicial decisions affecting contract pharmacy models and stakeholder responses, including implementation approaches for manufacturer rebate systems as alternative distribution strategies and their operational challenges
- Assess emerging state legislative measures designed to affect 340B program implementation, examining jurisdictional considerations and avenues for navigating overlapping federal and state requirements
- Examine strategic considerations at the intersection of 340B compliance and IRA implementation, focusing on methodologies for managing discount integrity across programs and adapting to evolving guidance on patient definition parameters
- Jennifer Plitsch - Partner, Covington & Burling
- Patrick Greene, PharmD - Director, Strategic Pricing & Contracting, Veloxis Pharmaceuticals
- Identify how 340B program dynamics influence cross-functional operations, including field sales, product lifecycle planning, distribution strategy, and financial forecasting considerations
- Showcase center of excellence structures that optimize program management across legal, finance, market access, and government pricing functions, with case studies on team composition and collaboration
- Construct frameworks for communicating 340B implications to C-suite executives, including business impact quantification, risk assessment methodologies, and integration with broader pricing strategies
- Differentiate organizational models for 340B management, from siloed approaches to integrated centers of excellence, with insights on team structure, reporting relationships, and resource allocation
- Map data governance frameworks supporting both 340B program integrity and IRA requirements, including strategies for historical data retention relevant to Medicare negotiations
- Samantha Gross - Corporate Counsel, Pfizer Inc
- Matthew Fornataro - Partner, Arnold & Porter
- Explore significant state Medicaid policy innovations affecting pharmaceutical access and pricing, including alternative payment models, outcomes-based arrangements, and specialty pharmacy programs
- Understand the evolving landscape of state supplemental rebate negotiations, including multi-state purchasing coalitions and indication-based contracting approaches
- The implementation of state carve-out and carve-in decisions for pharmacy benefits and their impacts on utilization management, data reporting, and manufacturer contracting
- Develop effective engagement strategies with state Medicaid agencies in an era of increasing budget constraints and innovative payment approaches
Pharmaceutical manufacturers and third-parties (e.g., GoodRx) are increasingly adopting consumer-directed health care initiatives. These initiatives, which focus on giving patients enhanced choices and access to health care, may offer consumers “one stop” access to prescription drugs through cash-pay discount drug programs (that operate outside of insurance), telehealth prescribing, and/or online pharmacies. The market for these types of offerings is rapidly developing, presenting alternative channels to commercialize drugs, with a wide range of related legal considerations. This session will:
- Identify trends in consumer-directed health care initiatives, taking a detailed look at common structures
- Provide an overview of potential legal considerations and concerns
- Examine recent government scrutiny and enforcement actions
- Highlight key “watch outs” in implementing initiatives and options to mitigate risk
- Margaux Hall - Partner, Ropes & Gray LLP
- Alison Fethke - Counsel, Ropes & Gray LLP
- Eve Brunts - Partner, Ropes & Gray
- Outline essential MFP requirements and implementation status, including practical approaches for meeting program guidelines and strategic considerations for compliance across different company sizes
- Navigate treasury operation changes from traditional 45-day cycles to daily payment requirements, establishing cross-system integration between government pricing platforms and financial systems
- Guide manufacturers through September deadline preparations, covering documentation requirements, operational readiness assessments, and compliance verification processes
- Develop robust data governance frameworks for maintaining historical pricing information required for Medicare negotiations, including strategies for source documentation preservation and audit preparation
- Jennifer Lospinoso - Managing Director & Consulting Lead, Riparian
- Lynn Buhl - Senior Director, Riparian
- Josh O'Harra - Deputy General Counsel, Eli Lilly and Company
- Understand the specific considerations for physician-administered drugs entering Medicare negotiation in Round 3, including ASP reporting requirements and distinct operational challenges
- Assess the potential marketplace impacts of MFP on Part B drug reimbursement, formulary positioning, and future investment decisions for injectable and infused therapies
- Explore strategies for communicating with providers and health systems about Part B drug pricing changes and their potential effects on acquisition costs and administration fees
- Examine policy considerations and potential regulatory changes that may affect Part B drug pricing and reimbursement as IRA implementation evolves
- Natalie Morris - Director, Public Policy & Reimbursement, Takeda
- Compliance challenges, data management burdens, and resource constraints that impact hospital 340B programs daily
- First-hand accounts of how program disruptions directly affect vulnerable community members and hospital services
- The unseen administrative maze hospitals navigate to maintain care continuity amid policy shifts
- Hospital executives share practical pathways for manufacturer partnerships that acknowledge covered entity constraints
- Explore structured engagement models including advisory councils, voice-of-customer sessions, and formal feedback mechanisms that maintain compliant relationships while gathering actionable insights
- Thomasyna Sweed - 340B Pharmacy Services Coordinator, LifeSpring Health Systems
- Tess Morgan - Senior Manager, Product Diversion and Program Integrity, Pfizer
- Understanding differing risk profiles for different product archetypes
- Considerations to keep in mind prior to product launch
- Divergent tactics for different points in the product channel
- Maintaining positive relations with covered entities and vulnerable patient populations
- Michael Kurland - Vice President, Revenue Management & Compliance Solutions, EVERSANA
- Jim Burke - General Manager, Revenue Management Solutions, EVERSANA
Examine financial challenges and business decisions for products facing underwater pricing in Medicaid
Explore portfolio management approaches and market repositioning strategies from established manufacturers
Evaluate cross-functional frameworks for addressing negative margin products, including legal and market access considerations
Develop actionable insights for mature brands in an increasingly complex rebate environment
- Navigate evolving state transparency requirements while effectively safeguarding sensitive pricing information through proven trade secret protection strategies
- Understand current enforcement priorities and respond strategically to state inquiries based on recent case studies from Oregon, New York, and Colorado
- Develop cross-functional protocols to streamline reporting processes while maintaining consistency across multiple state submissions
- Implement practical approaches to engage constructively with state regulators while advocating for reasonable interpretations of disclosure requirements
- Judd Caulfield - Senior Counsel, Takeda Pharmaceuticals
- Sara Simon, JD - Counsel, Porzio, Bromberg and Newman
- Review practical experiences from the first invoicing cycles for inflation rebates, including calculation methodologies, dispute resolution processes, and system integration challenges
- Develop effective approaches for evaluating inflation rebate invoices and managing the compressed timeframe for appeals and adjustments
- Inspect the complex interplay between price increase decisions, inflation rebates, and other pricing considerations in today's regulatory environment
- Explore innovative strategies for maintaining product lifecycle value while navigating the constraints of inflation penalties across Medicare and commercial markets
- Establish cross-functional workflows connecting government pricing, finance, and treasury functions to manage the evolving payment requirements across inflation rebates and MFP implementation
- Design system integration approaches that ensure accurate calculation, timely payment, and proper financial reporting in the new regulatory landscape
- Roneil Narciso - Director - Strategic Pricing & Contracting, AVEO Oncology
- Dalton Wilkins - Associate Director - Government Pricing & Reporting, PharmaEssentia USA Corp
- Melody Hamel - Senior Operations Counsel, Viatris Inc
- Analyze early market signals regarding PBM and health plan treatment of MFP-negotiated products, including formulary positioning, prior authorization requirements, and utilization management strategies
- Develop commercial strategies that address the changing rebate dynamics for products subject to MFP, including approaches to maintaining competitive formulary positioning
- Understand the implications of IRA implementation on biosimilar and generic competition, including potential shifts in market entry timing and pricing strategies
- Explore the evolving landscape of patient affordability programs for products subject to MFP, including benefit design optimization and alternative access models
- Rosalind Davis - Director, Government Pricing and Contracts, CSL Vifor Pharma